Program Description

The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the orphan disease or condition to be studied is a ?rare disease or condition? and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.

General Information

Funding Opportunity Number

RFA-FD-15-001

Funding Opportunity Title

Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

Opportunity Category

Business and CommerceCommunity DevelopmentConsumer ProtectionEducationEnvironmentFood and NutritionHealthNatural ResourcesScience and Technology and other Research and Development

Funding Instrument Type

Grant

Category Explanation

Not Available

Number of Awards

10

Cost Sharing or Matching Requirement

No

Posted Date

December 9, 2014 (Tuesday)

Application Due Date

October 18, 2018 (Thursday)***Application Due Date(s): February 4, 2015; February 3, 2016; February 1, 2017; February 7, 2018.
Resubmission Due Date(s): October 15, 2015; October 14, 2016; October 16, 2017; October 15, 2018).
This FOA uses non-standard due dates